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Echo-AMY: Echocardiographic Characterization of Cardiac Amyloidosis: an Observational Study

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05760287
Collaborator
(none)
255
Enrollment
1
Location
97.8
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a mono-center observational ambispective study in which patients with cardiac amyloidosis evaluated at our institution will be enrolled.

The primary aim is to investigate echocardiographic findings, particularly using advanced echocardiographic techniques, such as two- and three-dimensional speckle-tracking analysis, that may be helpful in the differential diagnosis between cardiac amyloidosis and other cardiomyopathies with hypertrophic phenotype.

Secondary aims are: 1) to evaluate the reversibility of myocardial damage, assessed by echocardiography, in response to a newly available specific treatment for patients with transthyretin-related cardiac amyloidosis (tafamidis ) and its correlation with the clinical response 2) to investigate potential novel echocardiographic predictors of adverse cardiovascular outcomes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    255 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Echocardiographic Characterization of Cardiac Amyloidosis: an Observational Study
    Actual Study Start Date :
    Dec 9, 2022
    Anticipated Primary Completion Date :
    Dec 2, 2030
    Anticipated Study Completion Date :
    Feb 2, 2031

    Outcome Measures

    Primary Outcome Measures

    1. changes in echocardiographic parameters (in patients receiving or not specific treatment) [6 months]

      variation in global longitudinal strain, diastolic parameters and degree of ventricular hypertrophy

    2. cardiovascular outcomes [24 months]

      composite endpoint of death and heart failure hospitalization

    Secondary Outcome Measures

    1. major cardiac arrhythmias [24 months]

      bradyarrhythmia, new-onset atrial fibrillation, ventricular tachycardia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients with cardiac amyloidosis, defined according to the recommendation provided by the working group of the european society of cardiology, with clinical, electrocardiographic ed echocardiographic data at our institution and with at least one follow-up visit.
    Exclusion Criteria:

    • missing data

    • decline to the study participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione Policlinico Gemelli IRCCS Roma RM Italy 00168

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT05760287
    Other Study ID Numbers:
    • 5308
    First Posted:
    Mar 8, 2023
    Last Update Posted:
    Mar 8, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    echocardiography
    left ventricle
    Additional relevant MeSH terms:
    Amyloidosis

    Study Results

    No Results Posted as of Mar 8, 2023